Introduction
We previously reported the one-year results of this national prospective multicenter cohort study evaluating SC-IFX persistence, efficacy and tolerance after switch from IV-IFX in 426 patients with inflammatory bowel disease, finding a persistence of 95%. Patients were followed up for an additional year. We report here the week 104 results of this cohort.
Aims & Methods
IBD patients in steroid-free clinical remission (defined by a Harvey Bradshaw index (HBI) ≤ 4 for Crohn’s disease (CD), and partial Mayo Score (PMS) ≤ 2 with no subscore >1 for ulcerative colitis (UC)) for 6 months or more on IV-IFX, were enrolled in this prospective cohort if they switched to SC-IFX. Clinical (HBI, PMS), biological (CRP, fecal calprotectin (FC)) and pharmacological evaluations were performed at 3, 6, 12 and 24 months from switch. SC-IFX dosing could be increased, or drug changed, in case of clinical or biological relapse, as per investigator’s judgement.
Prespecified endpoints for the study extension were treatment persistence with or without dose escalation, proportion of patients in steroid-free clinical remission, in clinical remission, in PRO2 remission, in biomarker remission, of relapse-free persistence, of loss of response, of hospitalization, infections, adverse events and infliximab pharmacokinetic data at week 104. We present here the preliminary results.
Results
Among the 426 patients included in the analysis (72.4% with Crohn’s disease (CD), 27.5% with ulcerative colitis (UC); 45.1% females; median age 37 [interquartile range: 29-50] years; median disease duration of 12 years in CD, 13 years in UC), 56% were on IV-IFX standard dosing (5mg/kg 8-weekly) and 16% received combination therapy with an immunomodulator drug at baseline. Among patients with complete data until W48, SC-IFX persistence was 95.3% [95%CI: 93.2-97.5]; 319/367 (86.9%) were on steroid-free clinical remission.
At week 104, treatment persistence was 89.7% [95% confidence interval: 86.6%-92.9%]. When considering patients who required a dose escalation as persistent, persistence at week 104 was 92% [88%-95%]. Of the 300 patients who had a clinical evaluation at week 104, 292 (97.3%) patients were in clinical remission, all without steroids, and 238/281 (84.7%) patients were in biomarker remission. From inclusion to week 104, median HBI, PMS scores and faecal calprotectin did not change significantly. Median CRP increased significantly from 1 mg/L [1-4] to 2 mg/L [1-4] (p=0.008). Mean infliximab trough level at inclusion was 7.97µg/mL, while it reached 18.0 µg/mL at week 48 and remained stable at 18.54µg/mL at week 104. A total of 532 adverse events were reported in 241/426 patients (56.6%), of which 31 led to discontinuation of SC-IFX. Twenty severe adverse events (4.7%) were reported.
Conclusion
In this large multicenter prospective cohort of IBD patients in remission, two-year persistence without dose escalation of SC-IFX after switch from IV-IFX was 90%, supporting excellent efficacy and tolerance of SC-IFX. Updated results with longer follow-up will be available at the time of presentation.
Disclosure
Marianne HUPE: declares conflicts of interest with Abbvie, Takeda, Celltrion Healthcare, Pfizer, JJanssen, Lilly
Nicolas MATHIEU: declares consulting fees from Abbvie, Alphasigma, Celltrion Healthcare, Galapagos, Janssen, Lilly, Pfizer, Takeda, lecture fees from Abbvie, Alfasigma/Galapagos, Celltrion Healthcare, Janssen, Lilly, Mayoli-Spindler, Pfizer, Takeda, and has received research funding from, Celltrion Healthcare, Lessaffre, Lilly, Takeda
Frederic HELUWAERT: Abbvie, Takeda, Galapagos, Janssen, Lilly
Pauline RIVIERE: declares conflicts of interest with Abbvie, Celltrion Healthcare, Janssen
Xavier HEBUTERNE: reports board membership and lectures fees with Abbvie, Abivax, Alphasigma, Amgen, Celltrion, Eli Lilly, Ferring, Fresenius-Kabi, InDex Pharmaceuticals, Janssen, MSD, Pfizer, Roche, Sanofi-Advantis, Takeda, Theravance, Tillots, Viatris
Philippe SEKSIK: reports consulting fees from Pfizer, Astellas, Janssen, Fresenius Kabi, Takeda, Abbvie, Merck-MSD, Pilège, Lilly, Celltrion and Biocodex; and grants from Biocodex and Janssen.
Vered ABITBOL: received board membership and lecturing fees from Takeda, Amgen, Sandoz, Janssen, Celltrion, Pfizer, Alfasigma, Nordic Pharma, Abbvie, Lilly, Ferring
Guillaume BOUGUEN: declares conflicts of interest with Abbvie, Amgen, Biogen, Celltrion, Fresenius Kabi, Galapagos, Gilead, Janssen, Lilly, Pfizer, Takeda, Sandoz.
Lucine VUITTON: has received fees for lecture, consulting or congress from Abbvie, Amgen, Viatris, Celltrion, Janssen, Takeda, Lilly, Pfizer, Dr Falk Pharma, MSD, Ferring, Galapagos
Jean-Marc GORNET: declares conflicts of interest with Abbvie, Amgen, Celltrion Healthcare, Fresenius-Kabi, Gilead, Janssen, Mylan, MSD, Takeda, Sanofi.
Stéphane NANCEY: declares counseling, boards, transports or fees from Abbvie, Alphasigma, Amgen, Celltrion, Ferring, Fresenius-Kabi, Janssen, Lilly, Medac, Pfizer, Sandoz, Takeda.
Guillaume CADIOT: declares conflicts of interest with Lilly, Abbvie, Takeda, Galapagos
Pauline WILS: received fees for lectures or consulting from Abbvie, Amgen, Ferring, Janssen, Takeda, Lilly, Celltrion
Cyrielle GILLETTA: received board membership and lecture fees from Abbvie, Alfa-Sigma, Amgen, Celltrion, Galapagos, Janssen, MSD, Pfizer and Takeda
Astrid DE MAISSIN: received board membership and lecturing fees from Abbvie, Takeda, Galapagos
Romain ALTWEGG: reports Advisory boards from Abbvie, Takeda, Celltrion, Janssen, Biogen, Amgen, Sandoz, Galapagos, Lilly, Pfizer
Laurianne PLASTARAS: received board membership and lecture fees from Abbvie, Amgen, Celltrion, Galapagos, Janssen, MSD, Pfizer and Takeda
Philippe AH-SOUNE: declares no conflict of interest
Arnaud BOURREILLE: declares conflicts of interest with Abbvie, MSD, Ferring, Janssen, Galapagos, Gilead, Roche, Medtronic, Ose Immunotherapeutics, Tillotts, Mayoli, Celltrion
Carmen STEFANESCU: declares conflicts of interest with Abbvie, Ferring, Tillots, Takeda, Janssen, Biogen, Amgen, Pfizer, Celtrion, Gilead, Alphasigma, Lilly
Philippe SEKSIK: reports consulting fees from Pfizer, Astellas, Janssen, Fresenius Kabi, Takeda, Abbvie, Merck-MSD, Pilège, Lilly, Celltrion and Biocodex; and grants from Biocodex and Janssen.
Marion SIMON: declares conflicts of interest with Abbvie, Amgen, Biogen, Celltrion, Fresenius Kabi, Galapagos, Takeda.
Mathieu UZZAN: declares counseling, boards, transports or fees form Abbvie, Amgen, Celltrion, Ferring, Fresenius, Galapagos, Janssen, Pfizer and Takeda.
Pierre ANDRAU: declares no conflict of interest
Cléa ROUILLON-GREUB: declares conflicts of interest with Abbvie, Janssen, Biogen , Galapagos, Celltrion, Lilly
Yves ARONDEL: declares conflicts of interest with Abbvie, Janssen
Anthony BUISSON: declared consulting fees from Abbvie, Amgen, Arena, Biogen, Celltrion Healthcare, Ferring, Galapagos, Janssen, Mylan, Nexbiome, Pfizer, Roche, Sandoz, Takeda, Tillotts; lecture fees from Abbvie, Alfasigma/Galapagos, Amgen, Biogen, Celltrion Healthcare, Ferring, Fresenius-Kabi, Janssen, Lilly, Mayoli-Spindler, MSD, Pfizer, Roche, Sanofi-Aventis, Takeda, Tillotts, Vifor-Pharma; and has received research funding from Abbvie, Alfasigma/Galapagos, Celltrion Healthcare, Lessaffre, Lilly, Pfizer, Takeda.
Laurent PEYRIN-BIROULET: declare conflicts of interest with Abbvie, Abivax, Adacyte, Alimentiv, Amgen, Applied Molecular Transport, Arena, Banook, Biogen, BMS, Celltrion, Connect Biopharm, Cytoki Pharma, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Gossamer Bio, GSK, IAC Image Analysis, Index Pharmaceuticals, Inotrem, Janssen, Lilly, Medac, Mopac, Morphic, MSD, Nordic Pharma, Novartis, Oncodesign Precision Medicine, ONO Pharma, OSE Immunotherapeuthics, Pandion Therapeuthics, Par' Immune, Pfizer, Prometheus, Protagonist, Roche, Samsung, Sandoz, Sanofi, Satisfay, Takeda, Telavant, Theravance, Thermo Fischer, Tigenix, Tillots, Viatris, Vectivbio, Ventyx, Ysopia
David LAHARIE: declares counseling, boards, transports or fees from Abbvie, Alphasigma, Amgen, Biogen, Celltrion, Ferring, Janssen, Lilly, Medac, MSD, Pfizer, Prometheus, Sandoz, Takeda.
